FDA 510(k) Application Details - K052240

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K052240
Device Name Detector And Alarm, Arrhythmia
Applicant CARDIONET, INC
1010 2ND AVE., SUITE 700
SAN DIEGO, CA 92101 US
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Contact JACK GAIKWAD
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 08/17/2005
Decision Date 10/19/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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